A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma - ND

Onyx Therapeutics, Inc.0 个研究点目标入组 792 人开始时间: 2011年6月14日最近更新: 2021年12月21日

适应症

试验速览

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•1. Symptomatic multiple myeloma 2. Measurable disease, as defined by one or both of the following (assessed within 14 days prior to randomization): o Serum M-protein = 0.5 g/dL o Urine Bence-Jones protein = 200 mg/24 hours 3. Prior treatment with at least one, but no more than three, regimens for multiple myeloma 4. Documented relapse or progressive disease on or after any regimen (subjects refractory to the most recent line of therapy are eligible) 5. Achieved a response to at least one prior regimen (defined as = 25% decrease in M-protein [or total protein in countries in which electrophoresis is not routinely available]) 6. Age = 18 years 7. Life expectancy = 3 months 8. Eastern Cooperative Oncology Group performance status 0–2 9. Adequate hepatic function, with serum ALT = 3.5 times the upper limit of normal and serum direct bilirubin = 2 mg/dL (34 µmol/L) within 14 days prior to randomization 10. Absolute neutrophil count = 1.0 ? 109/L within 14 days prior to randomization
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. If previously treated with bortezomib (alone or in combination), progression during treatment 2. If previously treated with a lenalidomide and dexamethasone (len/dex) combination: o Progression during the first 3 months of initiating treatment o Any progression during treatment if the len/dex regimen was the subject’s most recent line of therapy 3. Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects who are intolerant to bortezomib are not excluded 4. Prior carfilzomib treatment 5. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 6. Waldenstr?m’s macroglobulinemia or IgM myeloma 7. Plasma cell leukemia (> 2.0 ? 109/L circulating plasma cells by standard differential) 8. Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization 9. Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization

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